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Sterile Compounding: Certificate Program

Sterile Compounding: Certificate Program

This hands-on program will take the participant through a series of sixteen one-hour workstations as they perform various functions essential for sterile compounding, such as media-fill tests, aseptic techniques for non-hazardous and hazardous drug compounding, designing facilities for optimal workflow, performing calculations for sterile compounding, working with automated compounding devices, detailing master formulation records, and preparing four sterile medications in a state-of-the-art ISO certified three-room cleanroom suite.

Course format

The Sterile Compounding: Certificate Program is a 2.5 day in-person program, comprised of two components:

  1. Sterile Compounding: Home Study Manual - must be completed prior to the hands-on lab training.
    1. 8 chapters | 30 contact hours | 3.0 CEUs.
  2. Sterile Compounding: Hands-on Lab Training. 
    1. 2.5 days | 20 contact hours | 2.0 CEUs.
  • Value-added material included - Sterile Compounding: Labs Online. This material is supplemental to the hands-on lab training and is not part of the requirements to complete the Certificate Program.
    • 25+ videos | 3 contact hours.

Intended audience

  • Compounding Supervisors
  • Personnel with oversight responsibilities
  • Compounding Personnel (Pharmacists and Pharmacy Technicians)
  • Cleaning and disinfection personnel
  • Inventory control managers
  • Personnel specialized in allergenic extracts
  • Inspectors

Course description

Home Study

The Sterile Compounding: Home Study Manual component of this activity addresses the fundamentals of quality management, calculations, and principles & techniques surrounding non-hazardous and hazardous compounded sterile preparations.

To review the full activity description for the Sterile Compounding: Home Study Manual click here.

Lab Training

This Sterile Compounding: Hands-on Lab Training is an effective training method for novice-to-experienced sterile compounding personnel and transforms theory into practice, bringing standards of practice to life.

Participants will rotate through a series of sixteen 1-hour workstations as they rehearse the role of designated person, inspector, cleanroom designer, and most importantly sterile compounder. Participants will focus on aseptic technique and aseptic processing for non-hazardous and hazardous drug compounding, explore facility design for optimal workflow, experience methods in environmental risk management, scale up with automated compounding devices, fine tune calculations for sterile compounding, detail a master formulation record and prepare four sterile medications in a state-of-the-art three-room cleanroom suite.

Sterile Compounding: Labs Online

Sterile Compounding: Labs Online is a convenient, self-paced, audiovisual experience for your sterile compounding needs, complementing the Sterile Compounding: Hands-on Lab Training. With over 25 on-demand videos and over two hours of video recordings, Labs On-Demand for sterile compounding features a face-to-face dialogue with an experienced sterile compounding pharmacist on garbing of non-hazardous and hazardous personal protective equipment, cleanroom workflow, and aseptic techniques.

Learning objectives

Pharmacists

  1. Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
  2. Demonstrate the use of closed system transfer devices for hazardous drug compounding
  3. Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
  4. Assess and perform adjustment calculations for drug form and certificate of analysis-related indications
  5. Perform overage calculations for a compounded sterile preparation
  6. Sketch a cleanroom suite for optimal workflow
  7. Complete a Master Formulation Record
  8. Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
  9. Summarize findings of a risk assessment, and then construct a corrective action and preventive action plan
  10. Summarize findings following an inspection, and then construct a corrective action and preventive action plan
  11. Operate electromechanical equipment (e.g., balance, automated compounded device, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator and pH meter)

Pharmacy technicians

  1. Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
  2. Demonstrate the use of closed system transfer devices for hazardous drug compounding
  3. Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
  4. Solve adjustment calculations for drug form and certificate of analysis-related indications
  5. Solve overage calculations for processing, sterility and endotoxin testing
  6. Sketch a cleanroom suite for optimal workflow
  7. Complete a Master Formulation Record
  8. Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
  9. Describe findings of a risk assessment, and then construct a corrective action and preventive action plan
  10. Describe findings following an inspection, and then construct a corrective action and preventive action plan
  11. Operate electromechanical equipment (e.g., balance, automated compounded device, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator, pH meter, and more)

Testimonials

“Having recently taken a position in a hospital setting, I decided to build on my basic knowledge of sterile compounding. I chose LP3 Network again, in my opinion, they are recognized as experts in this facet of pharmacy, and justifiably so.  I highly recommend this program to any person who has the desire to excel in their compounding skills, because you can only be one of the best, if you learn from the best.”

“The course provided me with valuable, relevant and applicable information on sterile compounding in the comfort of a beautiful practice site. The combination of highly knowledgeable instructors, didactic written materials, hands-on-practical experience in a state-of–the-art lab that reflects a matrix of sterility with sparkling glass and mirrors throughout, provided me with one of the finest programs in my 30+ year career. I came away with having a proactive, rather than reactive approach to the preparation of compounded medications. My confidence has been 'compounded', no pun intended!

Pauline A. D’Chiutiis | Pharmacist

“What a wonderful program! The instructors use different types of learning throughout the entire program to grab the attention of every type of learner, through lecture, hands-on, and peer education. The practical component puts all the literature into perspective and the instructors teaching this course are absolutely A1!

Stephanie Armstrong | Pharmacy Assistant

Financial support

This learning activity has received financial support from MEDISCA in the form of an educational grant.

Copyright

This CE Activity is Copyright © 2006-2024 LP3 Network.